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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5855_Библиотеки_им_академика_М_И_Перельмана.pdf
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
4.5. Other International Reliance and Harmonization Initiatives
The COV ID-19 pandemic (from 2020 to 2023), and the associated
closure of national borders as well as travel restrictions across
international boundaries, have prompted the need for regulatory
reliance more than ever before. NRAs are often under tremendous pressure to facilitate timely access to safe, eective and goodquality medicinal products, in particular to the domestic markets
but also to the wider global market. Historically, harmonization of
regulatory requirements started o as a trade-driven initiative by
the European Economic Community in the latter half of the 1970s.
Its original purpose was the development of a single common body
of pharmaceutical legislation and regulations among its Member
States. Since then, other regional and international harmonization
initiatives have emerged, and they include those of the:
• Access Consortium
• Association of Southeast Asian Nations (ASEAN)
• East African Community (EAC)
• European Medicines Agency (EMA)
• International Conference of Drug Regulatory Authorities
(ICDRA)
• International Council for Harmonization (ICH)
• International Coalition of Medicines Regulatory Authorities
(ICMRA)
• International Pharmaceutical Regulators Program (IPRP)
• Latin America/ Pan American Health Organization
• Pharmaceutical Inspection Co-operation Scheme (PIC/S)
• WHO Collaborative Registration Procedure (WHO CRP)
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
• WHO Prequalification Inspection for Medical Products
• ZaZiBoNa
4.5.1. Access Consortium
The key and overriding objective of the Access
Consortium is to build synergies and share
knowledge amongst the regulatory authorities
forming the Consortium, thereby enhancing
the eciency of each other’s regulatory systems. All medicines regulatory authorities face similar challenges
such as the management of increasing workload and the complexity of the medicinal products being submitted for approval. These
increasing workload and complexity add pressure on the limited
resources available to the regulators. The Access Consortium began
as a four-member ACSS Consortium comprising Australia, Canada,
Switzerland and Singapore, way back in 2007. Following Brexit, the
UK Medicines and Healthcare Products Regulatory Agency joined
ACSS in 2021 and since then the group has been renamed the Access
Consortium. The five-member Access Consortium comprised likeminded regulators with comparable medicines regulatory systems.
All are members of PIC/S, ICH and ICMRA. Furthermore, all are
cognizant of resource constraints, increasing workload and need for
timely access to medicines.
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Since its establishment, the Access Consortium has established at
least two working groups — one on new active substances and the
other on generic products. The working groups use a network of bilateral confidentiality agreements and Memoranda of Understanding
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
to conduct their work. The Access Consortium explores opportunities for information and work-sharing initiatives in areas including:
— assessing therapeutic product manufacturing sites
— post-market surveillance of therapeutic product safety
— assessment reports for medicinal products
— development of technical guidelines and regulatory standards
— collaboration on information technology (IT)
Over the years, there have been significant achievements from the
Access Consortium. Early in 2022, Vabysmo®, containing the active
ingredient faricimab, became the first new product approved by the
Access Consortium. For Vabysmo®:
• The innovator drug company submitted the product application
to all five NRAs of the Access Consortium at the same time.
• The review workload for Vabysmo® was divided among the five
NRAs.
• The company received only one set of consolidated questions
from the Access Consortium, instead of multiple sets of questions from each NRA.
• After the coordinated review, each of the five NRAs makes its
own decision whether to authorize the therapeutic product for
their country.
Since then, at least the Swissmedic and HSA have registered Vabysmo®
for two serious eye diseases, namely age-related macular degeneration and diabetic macular edema. Soon after, Cibinqo®, another new
product containing abrocitinib, had also been approved jointly by
the Access Consortium for the treatment of severe atopic dermatitis.
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
Despite facing key challenges such as presence of country-specific
requirements and diering risk-benefits analysis, the mutual needs
for collaboration and reliance drive the Access Consortium forward.
4.5.2. Association of Southeast Asian Nations (ASEAN)
See Chapter 2.
4.5.3. East African Community (EAC)
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The EAC is a regional intergovernmental organization of six Partner States, namely, the Republics of Burundi, Kenya, Rwanda,
South Sudan, Uganda, and the United Republic of Tanzania. EAC
has its headquarters in Arusha, Tanzania. The EAC is home to about
180 million East African citizens, of which over 22% is urban population. With a land area of 2.5 million square kilometers and a combined Gross Domestic Product of US$193 billion (EAC Statistics for
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
2019), its establishment bears great strategic and geopolitical signif-
icance and prospects for the renewed and reinvigorated EAC. It has
been reported that the work of the EAC is guided by a treaty which
established the Community. The treaty was signed on 30 November
1999 and entered into force on 7 July 2000 following its ratification by the original three Partner States, namely, Kenya, Tanzania
and Uganda. The Republic of Rwanda and the Republic of Burundi
acceded to the EAC Treaty on 18 June 2007 and became full Members of the Community with eect from 1 July 2007. The Republic
of South Sudan acceded to the Treaty on 15 April 2016 and became
a full Member on 15 August 2016.
As one of the fastest-growing regional economic blocs in the world,
the EAC is widening and deepening cooperation among its Partner
States in various key spheres for their mutual benefit. These spheres
include political, economic and social aspects. At the moment,
the regional integration process is in full swing as reflected by the
encouraging progress of the East African Customs Union, the establishment of the Common Market in 2010 and the implementation
of the East African Monetary Union Protocol.
4.5.4. European Medicines Agency (EMA)
The EMA was established by the European
Union (EU) on 1 January 1995 to harmonize
the work of its existing national medicine regulatory authorities, as well as to centralize the
evaluation and supervision of medicinal products across EU Member
States. Since its formation, the EMA has been playing a crucial role
within the EU through the evaluation and supervision of medicinal
products before they are approved. Its primary responsibility is to
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
ensure the sa fety, ecacy, and quality of medicinal products available to patients within the EU.
The EMA evaluates applications for marketing authorization of new
medicinal products, including both human and veterinary drugs. It
assesses the scientific data provided by pharmaceutical companies
to determine whether a medicinal product meets the necessary
standards for approval. This evaluation process involves rigorous
scientific analysis and consultation with experts. Additionally, the
EMA monitors the safety of medicinal products once they are on the
market. It collects and analyzes data on adverse drug reactions and
takes appropriate regulatory actions to protect public health if any
safety concerns arise. EMA also provides scientific advice to pharmaceutical companies during the development of new medicinal
products, thus facilitating the availability of innovative and eective treatments. Furthermore, EMA collaborates with other NRAs
and international organizations to harmonize regulatory standards
and promote public health across Europe.
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EMA has a three-decade track record of ensuring ecacy and safety
of human and veterinary medicines across Europe and promoting
research and innovation in the development of medicinal products.
The success of EMA is based on cooperation within the European
Medicines Regulatory Network. This represents a unique partnership amongst the European Commission, the medicines regulatory
authorities in the European Economic Area countries and EMA.
Working together has encouraged the exchange of knowledge, ideas,
and best practices, thus ensuring the highest standards in the regulation of medicinal products. Today, more than half a dozen EMA scientific committees and more than 30 working parties provide scientific expertise for the regulation of medicines by drawing on a pool
of several thousand European scientific experts from the network.
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
The role of EMA has expanded over time in tandem with new EU
legislation. In addition to its role to evaluate human and veterinary
medicines, EMA is also responsible for products developed in the
specialized areas of medicines for rare diseases (since 2000), herbal
medicines (since 2004), medicines for children (since 2006) and
advanced therapy medicines (since 2007). Acquiring these responsibilities resulted in new scientific committees which provide expertise and scientific knowledge in these areas. With the establishment
of the Committee for Orphan Medicinal Products in 2000, EMA
had also opened its doors to patients and healthcare professionals.
Today, their representatives take part in most of EMA’s scientific
committees as full members, adding their unique perspective and
experiences to discussions. They play an increasingly important role
in the assessment of the risks and benefits of medicinal products.
With the creation of the Pharmacovigilance and Risk Assessment
Committee in 2012, EMA started to play an even more important
role in monitoring the safety of medicinal products across Europe.
As of January 2015, EMA has been implementing its landmark
policy on publishing the clinical data that underpin European
decision-making on medicinal products. This has provided an
unprecedented level of transparency for patients, healthcare professionals, academia and industry.
4.5.5. International Conference of Drug Regulatory
Authorities (ICDRA)
The ICDRA provides NRAs of WHO Member
States with a forum to meet and discuss ways and
means to strengthen collaboration. ICDRA has
been instrumental in guiding NRAs and interested stakeholders in determining priorities for
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
action in the national and international regulation of medicinal
products, including vaccines, biopharmaceuticals, and herbal products. NRAs are continually faced with new and challenging issues
such as globalization and extension of free trade. Increased responsibilities arising from market expansion and the improvement and
sophistication of products place heavy demands on regulatory systems and knowledge bases. The development of cutting-edge technologies and health care techniques and extensive use of the internet impose further complex challenges.
Conferences have been held since 1980 with the aim of promoting
exchange of information and collaborative approaches to issues of
common concern. As a platform established to develop international consensus, ICDRA continues to be an important tool for
WHO and medicines regulatory authorities in their eorts to harmonize regulation and improve the sa fety, ecacy and quality of
medicines. The program for each conference is developed by a planning committee of representative drug regulators. Topics discussed
may include quality issues, herbal medicines, homeopathy, regulatory reform, medicines safety, counterfeiting, access, regulation of
clinical trials, harmonization, new technologies and e-commerce.
Recommendations are proposed for action by NRAs, WHO and
related institutions.
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4.5.6. International Council for Harmonization (ICH)
4.5.6.1. Introduction
The ICH is unique in bringing together the regulatory
authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and
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Manufacture and Supply, Science and Reg ulation Towards High-Qua lity Medicinal Products
develop ICH guidelines. ICH was founded in 1990 with the aim to
harmonize the interpretation and application of technical guidelines for assessment of human medicinal products. The birth of ICH
took place at a meeting in April 1990 in Brussels. At this meeting,
representatives of the regulatory agencies and industry associations
of Europe, Japan and the US met to plan an International Conference on Harmonization; however, the meeting also discussed the
wider implications and terms of reference of ICH. The ICH initiative
has made significant contributions, in particular, to the establishment of a common technical dossier for the submission of product
applications for marketing authorization. ICH has also provided harmonized technical guidelines to improve eciencies of the national
medicines regulatory authorities to speed up the approval process.
4.5.6.2. ICH Members and Observers
Three geographical regions (the EU, the United States, and Japan)
were the originators of ICH. The founding regulatory members
of ICH were the European Commission of Europe, the FDA of
the United States and the Ministry of Health Labor and Welfare
/Pharmaceutical and Medical Device Agency of Japan. The purpose of ICH is to promote public health through international
harmonization of technical requirements that contribute to
the timely introduction of new medicinal products, and continued availability of the approved medicinal products to patients.
Another purpose of ICH is also to avoid unnecessary duplication
of clinical trials in humans, and to develop, register and manufacture safe, eective, and high-quality medicines eciently and costeectively. ICH also strives to minimize the use of animal testing
without compromising the safety and eectiveness of medicinal
products.
WHO Listed Authority and Other International Reliance and Harmonization Initiatives
Since its inception in 1990, ICH has gradually evolved and responded
to global developments in the pharmaceutical sector. ICH guidelines are increasingly being applied by a growing number of NRAs
globally. The mission of ICH is to achieve greater harmonization
worldwide to ensure that safe, eective and high-quality medicines
are developed, registered and maintained in the most resourceecient manner whilst meeting international standards. Since its
announcement of organizational changes in October 2015, ICH has
grown as an organization and now includes at least 21 Members and
37 Observers.
4.5.6.3. Future Direction
The future direction of ICH involves several key areas:
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• Expansion of Membership
ICH aims to expand its membership to include regulatory authorities from additional regions, such as Latin America, the Middle East,
and Africa. This will enhance global harmonization eorts and
ensure broader representation in the development of guidelines.
• Modernization of Guidelines
ICH will continue to update and modernize its existing guidelines
to reflect advancements in science, technology, and regulatory practices. This includes addressing emerging areas such as gene therapy,
digital health technologies, and personalized medicine.
• Enhancing Regulatory Convergence
ICH seeks to further promote regulatory convergence by encouraging regulatory authorities to implement and adopt ICH guidelines.